Connector assembly

ABSTRACT

A connector assembly includes a first fitting defining a first aperture, and a second fitting couplable to the first fitting and defining a second aperture. In some embodiments, each of the first and second fittings includes a sealing layer sealing its aperture. In other embodiments, each of the first and second fittings includes a removable layer overlying its aperture. The connector assembly may include a stem member which is mounted in the first fitting and includes a head axially movable into the aperture of the second fitting.

This disclosure is a continuation of patent application Ser. No.08/369,091, filed Jan. 5, 1995 and abandoned in favor of the presentdisclosure, which is a continuation of Ser. No. 956,854, now U.S. Pat.No. 5,393,101, filed Oct. 2, 1992.

FIELD OF THE INVENTION

The present invention relates to a connector assembly. Moreparticularly, the invention relates to a connector assembly whichmaintains the sterility of a fluid, for example, a biological fluid,which passes through the connector assembly.

BACKGROUND OF THE INVENTION

Connector assemblies have been developed to handle fluids, e.g.,biological fluids, while preserving their condition. More particularly,connectors have been developed to preserve the condition of a fluid, ormaintain a fluid free of contaminants. Freedom from contaminants refersto a relative amount of contaminants and is variously defined accordingto a specific industry, fluid and/or intended use. For example, abiological fluid which is substantially free of contaminants isconsidered free of viable micro-organisms, and is typically referred toas "sterile". Connector assemblies for use with biological fluids, forexample, have been fashioned to preserve sterility of the fluid.

Attempts have been made to develop connector assemblies which isolate afluid from the ambient environment of the connector, and fromcontaminants entrained in the ambient. Such connectors typically definea fluid conduit which is isolated from the ambient. Some conventionalconnector assemblies include mating male and female connectors havingopposing, exposed surfaces. One surface may comprise the surface of amembrane, for example, while the other surface may comprise the surfaceof a rubber septum forming a blind end of an elastic, collapsible tube.These surfaces may be wiped with an antiseptic, then resiliently urgedin contact when the connectors are coupled. Other conventional connectorassemblies provide a removable protective cover on each opposing surfaceto be contacted. These covers must be removed prior to actually couplingthe connectors.

Many problems are associated with these conventional connectorassemblies. For example, wiping the surfaces with an antiseptic orremoving the covers of these conventional connector assemblies may notsufficiently protect the fluid flowing through these assemblies. Thesurfaces are wiped and the covers are removed usually by hand. Althoughthe attendant may use surgical gloves, a gloved finger may trail theantiseptic wipe along the protected surface, depositing on the surfacecontaminants that were on the glove. To unfasten and remove a cover, thegloved hand must manipulate the removable cover in intimate proximity tothe protected surface under the cover, again risking incidental contactand the transmission of contaminants between the glove and the protectedsurface.

In addition, once the surfaces are wiped with an antiseptic or theprotective covers are removed from the protected surfaces, the surfacesare exposed to the contaminant-laden ambient environment. For example,as the connectors are brought together, dust, micro-organisms, and otherairborne contaminants may contact the protected surfaces, even if theconnectors are quickly mated. Thus, while these conventional connectorassemblies have been developed to form a sterile connection, noneadequately protect the fluid flowing through the connector assembly.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a connector assemblycomprises a first fitting defining a first aperture, a second fittingdefining a second aperture, a first membrane assembly sealing the firstaperture, a second membrane assembly sealing the second aperture, and anaxially resilient seat disposed between the first and second fittings.The axially resilient seat urges the first and second fittings intobiased opposition to maintain the first and second membrane assembliesin positive contact. The axially resilient seat includes a first sectioncomprising a substantially cylindrical hub and a resilient connector.The cylindrical hub has a first diameter and defines a rim upon whichthe first membrane assembly is disposed. The resilient connectorconnects the first section to the first fitting and provides an axiallyresilient connection between the first section and the first fitting.The resilient connector includes a neck having a second diameter lessthan the first diameter. The resilient seat and the first fittingcomprise a single, integral molded structure formed from a polymericmaterial.

In accordance with another aspect of the invention, a connector assemblycomprises a first fitting defining a first aperture, a second fittingdefining a second aperture, a first removable contamination containmentlayer overlying the first aperture, a second removable contaminationcontainment layer overlying the second aperture, and an axiallyresilient seat disposed between the first and second fittings. The firstand second fittings are couplable to provide positive contact betweenthe first and second removable contamination containment layers. Theaxially resilient seat includes a substantially cylindrical hub having afirst diameter and a neck having a second diameter less than the firstdiameter. The hub defines a rim, and the first contamination containmentlayer removably contacts the rim of the hub.

In accordance with still another aspect of the invention, a connectorassembly comprises a first fitting defining a first aperture, a secondfitting defining a second aperture, a first removable contaminationcontainment layer overlying the first aperture, a second removablecontamination containment layer overlying the second aperture, and anaxially resilient seat disposed between the first and second fittings.The first and second fittings are couplable to provide positive contactbetween the first and second removable contamination containment layers.The axially resilient seat includes a substantially cylindrical hub anda neck, and at least one of the hub and neck is axially compressible.The hub defines a rim, and the first contamination containment layerremovably contacts the rim.

In accordance with yet another aspect of the invention, a connectorassembly comprises a first fitting, a second fitting, a resilientcoupling mechanism, an interlock mechanism, and a stem member. The firstfitting defines a first aperture and includes a first removablecontamination containment layer overlying the first aperture. The secondfitting defines a second aperture and includes a second removablecontamination containment layer overlying the second aperture. Theresilient coupling mechanism is positioned between the first and secondfittings at the first and second apertures. The interlock mechanismincludes at least one tongue. The tongue extends between the first andsecond fittings and is adapted to engage a corresponding surface tointerlock the first and second fittings. The first and second fittingsare couplable to provide positive contact between the first and secondcontamination containment layers. The stem member is mounted in thefirst fitting and includes a head axially movable through the firstfitting into the aperture of the second fitting.

In accordance with yet still another aspect of the invention, aconnector assembly comprises a first fitting, a second fitting, aresilient coupling mechanism, an interlock mechanism, and a piercingmember. The first fitting defines a first aperture and includes a firstremovable contamination containment layer overlying the first aperture.The second fitting defines a second aperture and includes a secondremovable contamination containment layer overlying the second aperture.The resilient coupling mechanism is positioned between the first andsecond fittings at the first and second apertures. The interlockmechanism includes at least one tongue. The tongue extends between thefirst and second fittings and is adapted to engage a correspondingsurface to interlock the first and second fittings. The first and secondfittings are couplable to provide positive contact between the first andsecond contamination containment layers. The piercing member is mountedin the first fitting and is axially movable through the first fitting,through the sealing layers into the aperture of the second fitting

In accordance with a further aspect of the invention, a connectorassembly comprises a first fitting, a second fitting coupled to thefirst fitting, a stem member, and a breakable or severable element. Thefirst fitting defines a first aperture and includes a first removablecontamination containment layer overlying the first aperture. The secondfitting defines a second aperture and includes a second removablecontamination containment layer overlying the second aperture. The stemmember is mounted in the first fitting and includes a head axiallymovable into the aperture of the second fitting. The breakable orseverable element is positioned between the first fitting and the stemmember and provides resistance to axial movement of the stem member intothe second fitting.

In accordance with a still further aspect of the invention, a connectorassembly comprises a first fitting, a second fitting, an interlockmechanism, a stem member, and an axial restraint. The first fittingdefines a first aperture and includes a first removable contaminationcontainment layer overlying the first aperture. The second fittingdefines a second aperture and includes a second removable contaminationcontainment layer overlying the second aperture. The interlock mechanismincludes at least one tongue. The tongue extends between the first andsecond fittings and is adapted to engage a corresponding surface tointerlock the first and second fittings. The first and second fittingsare couplable to provide positive contact between the first and secondcontamination containment layers. The stem member is mounted in thefirst fitting and includes a head axially movable through the firstfitting into the aperture of the second fitting. The axial restraint iscoupled to the stem member to resist retraction of the stem member fromthe second fitting.

In accordance with yet further aspect of the invention, a connectorassembly comprises a first fitting, a second fitting, an interlockmechanism, a piercing member, and an axial restraint. The first fittingdefines a first aperture and includes a first removable contaminationcontainment layer overlying the first aperture. The second fittingdefines a second aperture and includes a second removable contaminationcontainment layer overlying the second aperture. The interlock mechanismincludes at least one tongue. The tongue extends between the first andsecond fittings and is adapted to engage a corresponding surface tointerlock the first and second fittings. The first and second fittingsare couplable to provide positive contact between the first and secondcontamination containment layers. The piercing member is mounted in thefirst fitting and axially movable through the sealing layers into theaperture of the second fitting. The axial restraint is coupled to thepiercing member to resist retraction of the piercing member from thesecond fitting.

In accordance with yet still further aspect of the invention, aconnector assembly comprises a first fitting, a second fitting coupledto the first fitting, a stem member, and a ratchet mechanism. The firstfitting defines a first aperture and includes a first removablecontamination containment layer overlying the first aperture. The secondfitting defines a second aperture and includes a second removablecontamination containment layer overlying the second aperture. The stemmember is mounted in the first fitting and includes a head axiallymovable through the first fitting into the aperture of the secondfitting. The ratchet mechanism is mounted to the stem member to lock thestem member within the second aperture of the second fitting.

The novel features and characteristics of this invention are set forthwith particularity in the appended claims. However, the invention maybest be understood with reference to the drawings, described below, andthe accompanying detailed description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view, in partial section, of disassembledcomponents of a connector assembly in one embodiment according to theinvention.

FIG. 2 is plan view of a female connector in the embodiment of FIG. 1.

FIG. 3 plan view of a male connector in the embodiment of FIG. 1.

FIG. 4 is an elevation in cross section of a resilient mount in theembodiment of FIG. 1.

FIG. 5a is a schematic of one embodiment of a membrane assemblyaccording to the invention.

FIG. 5b is a schematic of another embodiment of a membrane assemblyaccording to the invention.

FIG. 6 is an elevation view in partial section of the components of FIG.1 in partial assembly.

FIG. 7 is an elevation view in partial section, of the components ofFIG. 1 in final assembly.

FIG. 8 is an elevation view in partial section of a male connector inanother embodiment of a connector assembly according to the invention.

FIG. 9 is an elevation view in partial section of the male connector ofFIG. 8, in final assembly.

FIG. 10 is an elevation view in section of another embodiment of afemale connector in a connector assembly according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

A connector assembly according to the present invention includes matingconnectors or fittings which can be coupled to connect different fluidconduit sections, defining a fluid flow path. The connector assemblyisolates the fluid flow path from the ambient environment and fromcontaminants present in the ambient environment and is preferablysterile. Consequently, a connector assembly according to the presentinvention is suitable for use in an open system, a closed system, or aclosed sterile system.

In a preferred embodiment illustrated in FIGS. 1-3, the connectorassembly comprises two connectors, preferably a female connector 100 anda male connector 200. Each connector may be attached to any suitablefluid conduit section, for example, an inlet or outlet of a housing suchas a blood filter. In the illustrated embodiment, the fluid conduitscomprise sections of tubing 10, 20. Each connector may comprise anystructure suitable to conduct fluid communication, e.g. a housing of anyform capable of containing fluid. The exemplary.female connector 100generally comprises a fitting 130 and a membrane assembly 170. Theexemplary male connector 200 generally comprises a stem 210, a fitting230 and a membrane assembly 270.

In the disassembled view of FIG. 1, the connectors are disposedgenerally opposing each other. For directional orientation in thefollowing discussion, each connector has a proximate end, nearest theopposing connector, and a distal end, furthest from the opposingconnector. Also, since the exemplary connectors 100, 200 in FIG. 1comprise generally elongated bodies, the term axial denotes dispositionalong their axes.

The female And male connectors may comprise a detent mechanism adaptedto interlock the female connector in predetermined relation with themale connector. Thus, the female fitting 130 may include a bracket 148.The bracket 148 may be variously configured. The bracket 148 maycomprise a socket or cup having any suitable plan form, e.g. rectangularor circular. In the illustrated embodiment, the bracket 148 comprises aU-shaped bracket or clevis. The representative bracket 148 is defined bya flange 150 and side walls 156. The flange 150 may assume a radiallyextending annular plan form, for example, as best seen in FIG. 2.

The side walls 156 depend away from the flange 150 and toward theopposing male connector 200. Tongues 158 may depend from the walls 156.The tongues 158 can be formed integrally with the walls 156, forexample, by continuing middle sections of the walls 156. The tongues 158can thus register in grooves 248 formed in a flange 246 of the maleconnector 200, best seen in FIG. 6. Accordingly, tongues 158 can beadapted to couple the female and male connectors 100, 200 in atongue-in-groove engagement, as seen in the elevation view of FIG. 6 (inpartial assembly). Tapers 162 can be formed at the proximate ends of thetongues 158 to guide the insertion of the tongues 158 into the grooves248. Catches 160 can be formed which pass through the grooves 248,abutting a distal surface of the flange 246 and antagonistically lockingthe female and male connectors 100, 200, as will be detailed below.

A socket 164, adapted to receive the male connector 200, is defined bythe space enclosed by the flange 150 and side walls 156. The proximatesurface of the flange 150 (i.e. the flange surface closest the opposingmale connector) provides a socket seat 152. The seat 152 serves as anabutment to the male connector 200 when the latter is positively engagedwith the female connector 100.

The female fitting 130 may define an internal chamber or aperture 141which may have any suitable configuration. The illustrated chamber 141may comprise a bore 142 relieved at its proximate end into a counterbore144. The flange sear 152 surrounds the counterbore 144. The illustrativefemale fitting 130 may be connected integrally with the section oftubing 10. The internal chamber 141 may be connected in fluidcommunication with the tubing 10.

In an important aspect of the invention, the female connector is adaptedto contain fluid communication and preferably defines an isolatedportion of the fluid path. Accordingly, the chamber 141 is enclosed by amembrane assembly 170. The assembly of the female and male connectors100, 200 may be surrounded by an atmosphere or ambient environmenthaving contaminants. In one key function, the membrane assembly 170isolates the chamber 141, and fluid therein, from the surroundingambient and from contaminants present in the ambient.. Regardless ofwhen or how the connector 100 is sterilized, the seal provided by themembrane assembly 170 is preferably secure enough to maintain thesterility within the chamber 141 of female connector 100.

The membrane assembly is preferably secured to the seat 152 of thefemale connector 100. Alternatively, the membrane assembly may bepositioned in any other suitable location, such as within the internalchamber and sealed to the walls of the bore or the counterbore. Themembrane assembly 170 can be secured to the seat 152 or the walls of thechamber 141 by a variety of means. Preferably, the membrane assembly 170can be secured by ultrasonic welding. Alternatively, the membraneassembly 170 may be secured by a heat seal or bonded by an adhesive or asolvent, preferably along the periphery.

FIGS. 1, 6, and 7 show elevation views of the male connector 200 indifferent stages of assembly with the female connector 100. FIGS. 1, 6,and 7 comprise views in partial section, as the stem 210 is shown inplain (i.e. non-sectioned) elevation. The male connector 200 generallyincludes a stem 210 housed in a fitting 230. The male connector 200 mayalso include a resilient mount 249 having a membrane assembly 270secured thereto.

The male connector 200 is preferably adapted to contain and conductisolated fluid communication. Accordingly, the stem 210 is preferablyhoused within a sealed chamber or aperture 231 defined within thefitting 230. In the illustrative embodiment, the stem 210 is hollow,defining a lumen (not shown) therein. The proximate end of the stem 210may have a head 220 formed thereon. The head 220 may comprise a piercingelement since it may have a sharpened tip. The head 220 may have anaperture providing fluid access between the lumen and the exterior ofthe stem 210. The stem 210 may also be connected to a fluid conduitsection, e.g., the tubing section 20. If the stem 210 and tubing 20 arefabricated as separate components, the tubing 20 may be joined to thebase 223 using solvent, bonding or ultrasonic welding for example.Alternatively, the stem 210 and tubing 20 (or other fluid conduitstructure) may be molded as an integral part. The stem 210 may also beformed with a ratchet structure, for example beveled annular ribs 216formed on the external surface of the stem 210. These ribs 216 are shownin plain, non-sectioned elevation in the partially cross sectioned FIGS.1, 6 and 7. The ribs 216 may circumfuse the external surface of the stem210. The ribs 216 may be beveled such that they project from the surfaceof the stem 210, extending distally toward the base 223 of the stem 210and forming an acute angle with the external surface of the stem 210.

Although the male connector may be variously configured, the illustratedmale connector 200 comprises an arrangement of telescoping elementsadapted to house at least a portion of the stem 210 within the internalchamber 231 in isolation from contaminants. Thus, by way ofillustration, the fitting 230 may have a generally cylindrical sleeve232 extending from the flange 246. The sleeve 232 defines a bore 234forming a portion of the internal chamber 231. The stem 210 may registerintimately with the sleeve 232. In the illustrated embodiment, a headportion 220 of the stem 210 is housed within the sleeve 232.

The illustrative male fitting 230 may further be constructed with asecond outside sleeve 238 concentrically disposed about the first sleeve232. The concentric sleeves 232, 238 may be connected by any appropriatemeans. In the representative embodiment, the fitting 230 is formed suchthat the sleeves 232, 238 and the flange 246 comprise integral portionsof the fitting 230. Preferably, the outside sleeve 238 isolates both thestem 210 and the interior bore 234 of the inside sleeve 232 fromexposure to the ambient. Thus, the axial length of the inside sleeve 232may be shorter than the axial length of the outside sleeve 238. Theremainder of the body of the stem 210 may be housed within an interiorbore 239 defined within the outside sleeve 238.

The stem 210 may include a telescoping seal assembly adapted to mate intelescoping engagement with one or both of the sleeves 232, 238 toisolate and preferably seal the internal chamber 231. Generally, thetelescoping seal assembly may be adapted to engage either sleeve,internally or externally. In the exemplary embodiment, the seal assembly225 may mate in telescoping engagement at least with the interior bore239 defined in the outside sleeve 238. The telescoping assembly mayinclude elastomeric or deformable elements which intimately engage thewalls of the interior bore 239. As shown in the representativeembodiment of FIGS. 1, 6, and 7, the illustrative telescoping assembly225 may include a plunger 226 and an O-ring 227 which fits within agroove in the plunger 226. Preferably the plunger 226 and/or the O-ring227 tightly engage the inside wall of the outside sleeve 238. Thisengagement advantageously isolates the interiors of both the inside andoutside sleeves 232, 238 from the ambient.

The telescoping seal assembly may also mate with the inside sleeve 232to seal the internal chamber 231. For this purpose, the distal end ofthe sleeve 232 may be formed with a rim 233. The rim 233 may assume atapered form as shown. The telescoping seal assembly 225 mayadditionally include a shoulder 224 formed on a base 223 of the stem210. The shoulder 224 may have a tapered form adapted to mate with thatof the rim 233, providing another seal for the chamber 231.

Although the illustrated embodiment comprises an arrangement oftelescoping elements, the male connector may include other arrangementsfor advancing the stem. For example, a screw mechanism with a ratchetmay be mounted between the outer sleeve and stem. The stem could then beadvanced by rotating the screw mechanism.

As exemplified in the plan view of the male connector 200 in FIG. 3, theflange 246 may be generally annular, circumfusing and extending radiallyfrom the sleeve 232. The flange 246 may be formed with the grooves 248.As mentioned above, the engagement of the tongues 158 of the femaleconnector 100 in the grooves 248 of the male connector 200 is part ofone possible structure for coupling the connectors 100, 200. Thiscoupling is shown in an initial stage of engagement in FIG. 6.

In an important aspect of the invention, the female and male connectorsmay form a resilient coupling mechanism for engaging these connectors inbiased opposition. Though this resilient coupling mechanism may befashioned in a variety of ways, in the exemplary embodiment, thiscoupling mechanism may include the resilient mount 249. A representativeconstruction for the resilient mount 249 is detailed in the sectionedelevation view of FIG. 4. The mount 249 serves as a seat which has atleast one of the membrane assemblies secured thereon and which is atleast axially resilient (e.g. at least resilient along an axis of thesleeve 232). The resilient mount 249 may be disposed generally betweenthe female and the male connectors 100, 200, providing antagonismbetween the coupled connectors. The resilient mount 249 could beconnected to the female connector 100. However, in the illustratedembodiment the resilient mount 249 is connected to the male connector200.

As best shown in FIG. 4, the mount 249 may include a resilient neck 252connecting a hub 250 to the flange 246. The exemplary hub 250 defines asealable seat surrounding an opening into the chamber 231. Thus, the hub250 may have a wall 256 defining a well 262. The wall 256 may have anannular plan form, for example, as best shown in FIG. 3. The well 262communicates with the bore 234 in the sleeve 232. Together, theillustrative bore 234 and well 262 form the internal chamber 231. Thewall 256 may further have a rim 258. This rim 258 forms the sealableseat circumfusing the well 262 which accesses the chamber 231. Themembrane assembly 270 is preferably secured to the rim 258, enclosingthe internal chamber 231.

As detailed particularly in FIG. 4, the neck 252 may be formed with ajoint having a recess or groove, shown generally at 260. The groovedjoint 260 connects the. neck 252 to the hub 250, on the distal side ofthe hub. When the connectors 100, 200 are engaged, the grooved joint 260yields, and the neck 252 is compressed at least axially. Thus, the axialresilience of the mount 249 urges the connectors into biased opposition,maintaining the membrane assemblies 170, 270 in positive contact. As onealternative to the grooved joint 260, the hub may be formed with a thinflange joining the neck.

The resilient mount 249 may be formed as an integral part of the malefitting 230. Thus, the sleeve 232, flange 246, neck 252 and/or hub 250may be molded integrally for example. In this embodiment, the malefitting 230, like the female fitting 130, is molded as a single partfrom any suitable polymeric material, for example olefinic compositionssuch as polypropylene, polyethylene, butadiene; acrylics;polycarbonates; or elastomers.

Preferably, the female and male connectors 100, 200 are interlocked inpredetermined relation and are resiliently coupled in antagonisticbiased opposition. The coupling structure on each connector may beproportioned relative to the other to produce an antagonistic coupling.As noted above, FIG. 6 shows the tongue-in-groove coupling of therepresentative female and male fittings 130, 230 in partial assembly.The catches 160 abut the distal surface of the flange 246, interlockingthe connectors 100, 200 in predetermined relation to each other. Thedimensions of the fittings 130, 230 are preferably proportioned suchthat when the catches 160 embrace the distal surface of the flange 246,the resilient mount 249, including the hub 250 and neck 252, compressesaxially, forces the membrane assemblies 170, 270 into positive contact,and provides biased opposition between the membrane assemblies 170, 270.To protect the resilient mount 249, shoulders 154a-154d, seenparticularly in FIGS. 1 and 2, may be formed preferably on the flange148 of the female connector 100. These shoulders may serve as stopslimiting the compression of the mount 249 by ensuring a minimum spacingbetween the connectors. Alternatively, the mount 249 may be constructedsuch that it can tolerate compression that is limited by contact betweenthe flanges 148, 246 and the hub 250.

Prior to coupling the connectors 100, 200, the proximate, opposingsurfaces of the membrane assemblies 170, 270, are exposed to the ambientenvironment. Upon coupling, these opposing surfaces are forced intopositive contact with each other due to the biased opposition imposed bythe resilient mount 249. In a principal feature of the invention, thispositive contact is maintained as long as the connectors 100, 200 arecoupled. Through this positive contact, the contacting surfaces of themembrane assemblies 170, 270 cover each other, isolating them from theambient.

The membrane assemblies of the connectors may be variously configuredand may. be identical or not. FIGS. 5a and 5b are schematics showingdifferent embodiments for the membrane assemblies. In a principal aspectof the invention, each membrane assembly includes at least two layers orsurfaces. The first comprises a removable contamination containmentsurface. Initially, this surface comprises the proximate surface of eachrespective membrane assembly, i.e., the surface nearest and facing theopposing connector. The second surface of each membrane assemblycomprises a protected sealing surface. This surface is protected andpreferably isolated from the ambient environment and from contaminantspresent in the ambient environment. At least initially, prior to thestage of inserting the stem into the female connector, the sealingsurface seals the chamber defined within each respective fitting. InFIGS. 5a and 5b, in the membrane assembly 170 of the female connector100, the sealing surface and the contamination containment surface aredenoted by 174 and 182, respectively. in the membrane assembly 270 ofthe male connector 200, the sealing surface and the contaminationcontainment surface are denoted 274 and 282, respectively.

The layers or surfaces of the membrane assemblies may be variouslyconfigured. In the exemplary embodiment of FIG. 5a, the contaminationcontainment surface comprises a surface of a cover layer which may becompletely removed from the membrane assembly. This exposes a separateunderlying sealing layer, having the sealing surface as one of itssurfaces. In the embodiment of FIG. 5b, the contamination containmentsurface comprises a portion of a surface of a cover layer which isfolded in a serpentine configuration. This cover layer may be unfolded,exposing a protected cover layer portion, or may be removed completely,exposing a separate sealing layer.

FIG. 5a shows one preferred embodiment of the membrane assemblies 170a,270a. Each membrane assembly 170a, 270a, in the illustrative embodiment,comprises two separate layers. The membrane assembly 170a has a coverlayer 178a serving as a removable protective sheath covering a separatesealing layer 172a. The sealing surface 174a comprises the surface ofthe sealing layer 172a facing the female flange 148. The contaminationcontainment surface 182a comprises the surface of the cover layer 178afacing the male connector 200.

More particularly, the sealing layer 172a may enclose the chamber 141defined within the female fitting 130, preferably sealing it. Thus, thesealing surface 174a may be secured to the seat 152, preferablypermanently, using any of the techniques discussed above, e.g.ultrasonic welding. In this embodiment the sealing layer 172a is laidflat over the opening to the chamber 141 and because the sealing layer172a has no folds, it has only two surfaces, the sealing surface 74a andan intermediate surface 176a. Also preferably, the sealing layer 172amay comprise a material which precludes the passage of bacteriatherethrough. This material my be porous, preferably having a porerating of about 0.2 μm or less. Alternatively, the sealing layer 172amay comprise a material which is impervious to both liquid and gas.Accordingly, in one key function the membrane assembly 170a isolates aportion of the fluid path from the ambient environment and fromcontaminants in the ambient environment since the sealing layer 172aseals the chamber 141.

In the illustrated embodiment, the cover layer 178a is disposed over thesealing layer 172a in a single fold configuration. The exemplary coverlayer 178a has a pull tab 179a (shown also in FIG. 2), an intermediatesurface 180a and the contamination containment surface 182a. When thecover layer 178a is attached to the sealing layer 172a, the intermediatesurface 176a of the sealing layer 172a and the intermediate surface 180aof the cover layer 178a are interfaced in intimate contact. The coverlayer 178a is preferably removably attached to the sealing layer 172a inany suitable manner. The sealing layer 172a and the cover layer 178a canbe attached together by heat sealing the perimeter of the intermediatesurfaces 176a, 180a, for example. Alternatively, the intermediatesurface 180a, but not the contamination containment surface 182a, of thecover layer 178a has a tackiness or an adhesive which releasably holdsthe cover layer 178a to the sealing layer 172a but which entirelyremains with the cover layer 178a when the cover layer 178a is removedfrom the sealing layer 172a. The contamination containment surface 182aof the cover layer 178a and the intermediate surface 176a of the sealinglayer 172a thus remain free of adhesive, preventing ambient contaminantsfrom being attracted to and held by either surface. Further, because theintermediate surface 176a of the sealing layer 172a remains free ofadhesive, there is no risk that the adhesive will leach into fluidflowing through the connector assembly.

Prior to coupling the female and male connectors 100, 200, thecontamination containment surface 182a is exposed to the ambientenvironment. Preferably, the cover layer 178a also comprises a material,such as glassine paper, which precludes the passage of bacteriatherethrough. Accordingly, while the cover layer 178a is attached to thesealing layer 172a, it isolates the sealing layer from the ambient. Inanother key function of the membrane assembly 170a, the cover layer 178aprotects the sealing layer 172a, isolating it from contact with othersurfaces, or surface area portions, or the ambient. More particularly,the cover layer 178a may be advantageously folded as shown so that theintermediate surface 180a intimately interfaces with the sealing layer172a and protects the sealing layer 172a from even the exposedcontamination containment surface 182a.

The membrane assembly 270a of the male connector 200 has a constructionanalogous to that of the membrane assembly 170a. The membrane assembly270a has a sealing layer 272a and a cover layer 278a. The sealingsurface 274a comprises the surface of the sealing layer 272a facing themale flange 246. The contamination containment surface 282a comprisesthe surface of the cover layer 278a facing the female connector 100.

The sealing layer 272a seals the well 262, and thus the chamber 231defined within the male fitting 230. Accordingly, the sealing surface274a is secured to the rim 258 of the axially resilient hub 250. Thesealing surface 274a may be secured, preferably permanently, using anyof the techniques outlined above, e.g. ultrasonic welding. The sealinglayer 272a may be laid flat over the well 262. Because the sealing layer272a has no folds ir. this embodiment, it has two surfaces, the sealingsurface 274a and an intermediate surface 276a. The sealing layer 272amay be impervious to gas or liquid or may comprise a porous, hydrophobicmaterial which precludes the passage of bacteria therethrough. Thesealing layer 272a thus isolates the chamber 231 from the ambient andfrom contaminants entrained in the ambient.

As in the female connector, the cover layer 278a may similarly beremovably attached to the sealing layer 272a. This cover layer 278a mayalso be disposed over the sealing layer 272a in a single foldconfiguration. The exemplary cover layer 278a has a pull tab 279a (shownalso in FIG. 2), an intermediate surface 280a and the contaminationcontainment surface 282a. When the cover layer 278a is attached to thesealing layer 272a, the intermediate surface 276a of the sealing layer272a and the intermediate surface 280a of the cover layer 278a areinterfaced in intimate contact. Accordingly, while the cover layer 278ais attached to the sealing layer 272a, it isolates the sealing layerfrom the ambient and from contact with other surfaces exposed to theambient.

In each of the previous embodiments of the membrane assemblies 170, 270,the cover layer 178, 278 intimately contacts the sealing layer 172, 272.However, the membrane assembly may alternatively be configured with thesealing layer spaced from the cover layer. For example, the cover layermay be removably attached to the flange of the connector, enclosing thechamber, while the sealing layer is spaced from the cover layer andpositioned within the chamber sealed to the walls of the bore.

The antagonistic coupling of the connectors created by thetongue-in-groove engagement and the axially resilient mount 249 urgesthe respective contamination containment surfaces 182a, 282a, intobiased opposition. This resilience ensures positive contact between thecontamination containment surfaces 182a, 282a as long as the connectors100, 200 are coupled.

Preferably, the fittings 130, 230, and thus the surfaces within thefittings defining the chambers 141, 231, may be sterilized either beforeor upon assembly with each other. Each of the sealing surfaces 174a,274a seals its respective chamber 141, 231, isolating the chamber fromthe ambient and contaminants entrained therein.

According to a principle aspect of the invention, each of thecontamination containment surfaces 182a, 282a can be removed whilemaintaining these surfaces in positive contact. Once the connectors 100,200 are coupled, they form a housing and the pull tabs 179a, 279a of thecover layers 178a, 278a preferably abut each other and extend in thesame direction to the exterior of the housing. For example, in theembodiment illustrated in FIG. 5a, the pull tabs 179a, 279a extend outof the channel of the U-shaped bracket 148 (i.e., into or out of theplane of the drawing page), beyond the assembly of the two connectors100, 200. The pull tabs 179a, 279a can be pulled by hand,-pinching thetabs together with two fingers. The tabs 179a, 279a are most preferablypulled simultaneously, while maintaining the contamination containmentsurfaces 182a, 282a in biased contact. When the tabs are pulledtogether, the biased opposition of the resilient coupling maintains thepositive contact between the contamination containment surfaces 182a,282a. Each contamination containment surface 182a, 282a may trap andisolate any contaminants on the other. Even as the cover layers 178a,278a are removed, the resilient mount 249 urges the contaminationcontainment surfaces 182a, 282a into positive contact with each other.Also, a bacteriostatic or bacteriocidal compound or layer could bedisposed on either or both contamination containment surfaces 182a,282a. As the cover layers 178a, 278a are removed, each contaminationcontainment surface 182a, 282a is pulled away from the respectivesealing layer 172a, 272a by virtue of the advantageous foldconfiguration. Thus, in another key feature the membrane assemblies170a, 270a isolate both the fluid path and surfaces intersecting thefluid path, e.g., the intermediate surfaces 176a 276a at the sealinglayers 172a, 277a, from the ambient and surfaces exposed to the ambient,e.g., contamination containment surfaces 182a, 282a.

In addition to being axially resilient, the resilient mount 249 ispreferably flexible enough to tilt laterally or rock as the cover layers178a, 278a are removed. Thus, as the cover layers 178a, 278a areremoved, the hub 250 instantly urges the protected intermediate surfaces176a, 276a of the sealing layers 172a, 272a into positive contact,virtually preventing contamination of these surfaces.

Each contamination containment surface 182a, 282a isolates the other,trapping therebetween any contaminants incident on the surfaces from theexposure of these surfaces to the ambient. The membrane assemblies 170a,270a isolate both internal chambers 141, 231, and the fluid path portiondefined within the stem 210, from the ambient. Further, the membraneassemblies 170a, 270a isolate both internal chambers 141, 231, and thefluid path portion defined within the stem 210, from surfaces exposed tothe ambient, e.g., from the contamination containment surfaces 182a,282a. When the two connectors 100, 200 are coupled and the cover layers178a, 278a are removed, only surfaces which were previously isolateddefine or intersect the fluid flow path.

In the embodiment of FIG. 5b, each membrane assembly 170b, 270bcomprises at least one sheet arranged in a serpentine foldconfiguration. Each fold defines a portion of the sheet forming a newlayer. Thus, the membrane assembly 170b can comprise a single sheethaving one portion forming the sealing layer 172b. Another portion ofthe sheet after the first fold in the serpentine configuration forms afirst cover layer 178b. Yet another portion of the sheet after thesecond fold in the serpentine configuration forms a second cover layer181b.

More particularly, the sheet portion forming the sealing layer 172b hastwo surfaces, a sealing surface 174b and an intermediate surface 176b.Analogous to the embodiment of FIG. 5a, the sealing surface 174b may besecured to the seat 152 of the female fitting 130, preferablypermanently. Preferably, the sealing layer 172b comprises a materialwhich precludes the passage of bacteria. Thus the membrane assembly 170bisolates a portion of the fluid path from the ambient and contaminantspresent in the ambient since the sealing layer 172b seals the chamber141.

The first cover layer 178b may be removably attached to the sealinglayer 172b as previously discussed with respect to the embodiment shownin FIG. 5a. The first cover layer 178b has an intermediate surface 180b.When the membrane assembly 170b is folded, the intermediate surface 176bof the sealing layer 172b and the intermediate surface 180a of the firstcover layer 178b are interfaced in intimate contact.

The second cover layer 181b may be disposed over the first cover layer178b. The second cover layer 181b has a pull tab 179b and acontamination containment surface 182b. The contamination containmentsurface 182b comprises the surface of the membrane assembly 170b mostproximate to the opposing male connector 200. Prior to coupling thefemale and male connectors 100, 200, the contamination containmentsurface 182b is exposed to the ambient. Preferably, the membraneassembly 170b comprises a homogeneous membrane sheet. Thus, both coverlayers 178b, 181b also preclude the passage of bacteria therethrough.Accordingly, while the cover layers 178b, 181b are protectively disposedover the sealing layer 172b, they isolate the sealing layer from theambient contaminants and from surfaces exposed to the ambient.

In the embodiment of FIG. 5b, the membrane assembly 270b of the maleconnector 200 can be constructed in a fashion analogous to the membraneassembly 170b of the female connector 100. Reference numerals forcomponents of the membrane assembly 270b are analogous to the numeralsfor the membrane assembly 170b, except that the 200 series is used.

In use, the hollow stem 210 forms an isolated portion of the fluidcommunication path. On the proximate side of the internal chamber 231 ofthe male connector 200, the membrane assembly 270 preferably seals thehollow stem 210 therein. On the distal side of the chamber 231, thetelescoping seas assembly 225 preferably seals the stem 210 therein. Asexemplified in FIG. 7, in final assembly the stem 210 is adapted tobridge the chambers 141, 231. Accordingly, the stem 210 is free to moveaxially within the bore 234, toward the proximate end of the malefitting 230.

To establish fluid communication between the internal chambers 141, 231,the connectors 100, 200 are first positively interlocked. The connectors100, 200 may be interlocked by the tongue-in-groove coupling describedabove, for example. The resilient mount 249 is then compressed and urgesthe cover layers of the membrane assemblies 170, 270 into positivecontact against each other. The cover layers 178, 278 can then beremoved by pulling the tabs 179, 279. The biased opposition provided bythe resilient mount 249 simultaneously urges the protected sealinglayers of the membrane assemblies 170, 270 into positive contact againsteach other.

The stem 210 then can be advanced within the male fitting 230 by hand,for example. The stem 210 may advance within the sleeves 232, 238 untilthe rim 233 formed on the distal end of the inside sleeve 232 abuts theshoulder 224 formed on the stem 210. The mating tapered surfaces of therim 233 and the shoulder 224 provide yet another seal isolating from theambient the internal chamber 231 as well as the stem portion or head 220therein. This abutment also serves as a stop, ultimately limiting theaxial travel of the stem 210. The advance of the stem 210 is sufficientto allow the stem 210 to pierce at least the sealing layer 172, 272 ofeach membrane assembly 170, 270, respectively. The head 220, whichcomprises a piercing element, may thus have a pointed form for example,adapted for this penetration. By inserting the stem 210 into the femalefitting 130, fluid communication is established between the female andmale connectors 100, 200. Thus, the tubes 10, 20 are joined in fluidcommunication, and a single fluid path is formed through the connectorassembly.

Preferably, once the stem 210 is inserted into the female fitting 130,an axial restraint resists retraction of the stem 210. Such a restraintpreferably prevents altogether the retraction of the stem 210. Thisrestraint is implemented in the illustrated embodiment by a ratchet orlocking structure. The inside sleeve 232, including the tapered form ofthe rim 233 cooperates with the angle of the beveled ribs 216 to allowaxial advance of stem 210 toward the female connector 100 withsufficient resistance to prevent accidental or incidental movement ofthe stem 210. The distal end of the inside sleeve 232 may further beformed with a lip or catch 236 depending radially inward within the bore234. Upon attempting retraction of the stem 216, the beveled ribs 216may engage the catch 236. This engagement prevents axial retraction ofthe stem 210, locking the stem within the female fitting 130. Theratchet structure may additionally include engagement of the beveledribs 216 by an internal shoulder 235 (shown in FIG. 4) formed in thebore 234 of the sleeve 232, for example.

The axial restraint may also be implemented or augmented by thefrictional telescoping engagement of mating parts. This includes thetelescoping engagement of the plunger 226 and/or O-ring 227 within thebore 239. Also, both the head 220 of the stem 210 and the bore 142defined within the female fitting 130 may comprise mating tapered forms.Accordingly, the head 220 may be lodged in frictional telescopingengagement within the internal chamber 141 of the female connector 100,sealing the stem 210 within the female connector 100 and resistingdisengagement.

In another representative embodiment shown in FIGS. 8 and 9, componentscorresponding to the previous embodiment are denoted with the samereference numerals. The illustrated seal assembly 225 may furtherinclude a frangible flange 243, in addition to the plunger 226. Theoutside sleeve 238 may have a seat assembly 240 formed at the distal endthereof. The frangible flange 243 may be fixed to the seat assembly 240by any appropriate means, e.g. by bonding or welding, and may thus sealthe interior bore 239 defined within the outside sleeve 238. The seatassembly 240 may include a rim 242 which abuts the frangible flange 243when the latter is fixed to the seat assembly. Preferably, the frangibleflange 243 comprises an element which may be severed or broken. moreparticularly, the frangible flange 243 may comprise a thin wall forexample. Further, the frangible flange 243 may have a cleavage or creaseformed on either side of the flange. The position of this crease wouldcoincide with the area where the rim 242 which abuts the frangibleflange 243. Also, the rim 242 may advantageously form a sharp edge.

The assembly of connectors 100, 200 of the embodiment of FIGS. 8 and 9may operate similarly to the earlier embodiment. After the connectors100, 200 are coupled and the removable cover layers are removed from themembrane assemblies 170, 270, the stem 210 can be advanced. The stem 210may be forcibly advanced by hand such that the flange 243 is severed orbroken against the rim 242. As the stem 210 is advanced, the plunger 226moves along the wall of the bore 239. The plunger 226 may again beadvantageously formed from a compressible material, for example anelastomeric material. Contact between the plunger 226 and the wall ofthe bore 239 provides a secure seal from the ambient for both bores 239,234 and the internal chamber 231. Also, part of the frangible flange 243remaining with the plunger 226 preferably comprises a material which mayyield, compressing radially or folding at its periphery, for example.Thus, the remaining portion of the severed flange 243 may initiallyenter and advance within the bore 239 while constantly maintainingsealed contact with the tapering wall defining the bore 239.

In summary, in this embodiment of the connector assembly, at least fourmechanisms advantageously cooperate to isolate from the ambient thedistal end of the internal chamber 231. originally, prior to advancingthe stem 210, the frangible flange 243 may be fixed to the seat assembly240, sealing the bore 239. Once the stem 210 is advanced, the peripheryof the remaining portion of the frangible flange 243 intimately contactsthe wall defining the bore 239. Similarly, the plunger 226 alsointimately contacts the tapering wall of the bore 239. Finally, theabutting tapered surfaces of the rim 233 of the inside sleeve 232 andshoulder 224 of the stem 20 mate to seal the bore 234.

As with all illustrated embodiments herein, a number of variations inthe illustrated constructions are envisioned. For example, anotherembodiment for the female connector 100 is illustrated in FIG. 10, whereanalogous components have the same reference numerals. In thisembodiment, the counter bore 144 is closed at a blind end by apierceable septum 147 and the septum 147 may comprise an integral partof the flange 150. Thus, the chamber 141 defined within the tubing 10 issealed by both the membrane assembly 170 and the septum 147. The septum147 may provide additional security in sealing the chamber 142 fromambient contaminants and from surfaces previously exposed to theambient. The septum 147 may also resist the pressure of the fluid in thetubing section better than the membrane assembly 170. When the femaleand male connectors 100, 200 are coupled, the stem 210 can be axiallyadvanced through the sleeve 232 to pierce three elements: the membraneassembly 270 of the male connector 200 and the membrane assembly 170 andthe septum 147 of the female connector. In one possible mechanism foraxial restraint of the stem, a throat may be formed where the septum ispierced, whereby the stem registers in an intimate friction fit withinthe throat.

Other variations are also envisioned. For example, where the femaleconnector and fluid conduit comprise separate components, they could beconnected by a variety of other means, e.g. mating threaded fittings.Alternatively, the bracket may be attached to a sleeve, either formedintegrally with the bracket or otherwise connected thereto. This sleevemay be connected to a section of tubing through telescopic engagement,i.e. a coaxial friction fit wherein one member is inserted within theother, with friction between the two members retaining the coupling. Inanother variant construction for the female connector, the two bores andthe tubing can be variously configured. In the exemplary embodiment ofFIGS. 1-3 these components are generally cylindrical. Alternatively,they may be formed with cross sections of various geometries, forexample rectangular or elliptical.

A number of variations are envisioned in the construction of the maleconnector. The hub and/or sleeve may assume cross sections of anysuitable form, for example rhomboid or trapezoidal. Also, the sleeve,flange and/or hub, for example, can be molded or machined as separateparts, each with mating threads. The sleeve can also be constructed asseparate, hollow telescoping sections housing a helical spring, forexample. This may serve as a substitute for the illustrated constructionof the resilient mount. The telescoping sections of the sleeve can bedimensioned to allow easy axial reciprocation of one half within theother. The spring would provide the resilience necessary to couple theconnectors in biased opposition, maintaining positive contact betweenmembrane assemblies. If the spring is helical, it can be sized such thatthe stem can be loosely housed, allowing for axial displacement withinthe helix. In another alternative to the illustrated construction of theresilient mount, the male fitting can alternatively be formed ormachined as an integral piece from a post of elastomeric material. Thispost would be bored to make it a hollow sleeve, and may be constructedwithout a separate hub piece. Alternatively, a separate elastomeric hubcan be mounted on a sleeve piece.

The axial resilience in the coupling can alternatively be provided byusing a deformable or resilient material for one or both sealing layersof the membrane assemblies. The resilience and thickness in the sealinglayer should provide the compliance and clearance necessary to urge thecontamination containment surfaces into positive contact. Hence, thesealing layers may be made thick relative to the cover layers. Theremovable cover layers may.be made thin relative to the sealing layersto make removal easy while assuring positive contact of interfacingintermediate surfaces.

The illustrated structure for coupling the female and male connectorscan also be modified. The exemplary tongue-in-groove coupling can bereplaced with any coupling, preferably an interlocking structure whichlocks or becomes non-separable after coupling. A rabbeted coupling, forexample, can be implemented by forming one connector with a groove orrecess cut out of an edge or face of its body. The other connector canbe formed with a boss or rib having a shape that mates with that recess.In another alternative coupling, the female and male connectors cancomprise any suitable form of mating threaded fittings.

Several alternative constructions for the axial restraint of the stemare possible. An axial restraint can be implemented by severalembodiments of a friction fit, for example. The counter bore within thefemale fitting may be proportioned to accommodate any flaps formed whenthe membrane assemblies are pierced. As the stem passes, the flaps canbe pressed radially against the inside wall of the counter bore. A tightfriction fit may be formed with the flaps of the pierced membrane caughtbetween the stem and the wall of the counter bore. Withdrawal of thestem from the female fitting may be prevented in part by friction.Forward edges of the membrane flaps may also engage the annular beveledribs, preventing withdrawal of the stem.

In another alternative for the axial restraint, the stem and the malefitting may be formed as telescoping parts, coaxially engaging in afriction fit. These components may have tapered or conic sections, forexample. Additionally or alternatively, these components may be formedwith a rabbeted structure, e.g., a rib or lug may be formed on onecomponent to engage in a mating recess formed in the other.

In the illustrated assembly of female and male connectors it may bedesirable to ensure that accidental or incidental insertion of the Stemthrough the membrane assemblies is prevented. Accordingly, the connectorassembly can additionally be equipped with a mechanism initiallypreventing insertion of the stem. In one embodiment, this mechanism maybe implemented by forming the proximate end of the stem with arelatively dull nipple rather than a head with a sharp tip.Additionally, the sealing and cover layers within a given membraneassembly could Comprise different materials, e.g., materials whichstrongly resist being pierced by the stem. The nipple may also have aform which can penetrate one of the sealing or cover layers, but not theother. In another embodiment, this mechanism may comprise a camstructure. The connector housing the stem, e.g. the male fitting 230 inthe illustrated embodiments, may have a slot formed in the sleeve andthe stem may be formed with a lug which serves as a cam. The cam canprevent axial advance of the stem when it abuts the rim of the sleeve,but upon twisting the stem to align the cam with the slot in the sleevethe stem 210 is freed from the locking action of the cam. The stem maythen be inserted into the female connector, piercing the membraneassemblies.

I claim:
 1. A connector assembly comprising:(a) a first fitting defininga first aperture; (b) a second fitting defining a second aperture; (c) afirst membrane assembly sealing the first aperture; (d) a secondmembrane assembly sealing the second aperture; (e) an axially resilientseat disposed between the first and second fittings and urging the firstand second fittings into biased opposition, thereby maintaining thefirst and second membrane assembly in positive contact, the axiallyresilient seat including a first section comprising a substantiallycylindrical hub having a first diameter and defining a rim upon whichthe first membrane assembly is disposed and a resilient connectorconnecting the first section to the first fitting and providing anaxially resilient connection between the first section and the firstfitting, the resilient connector including a neck having a seconddiameter less than the first diameter, the resilient seat and the firstfitting comprising a single, integral molded structure formed from apolymeric material.
 2. The connector assembly according to claim 1,wherein the resilient connector further comprises a grooved jointcooperatively arranged with the cylindrical neck.
 3. A connectorassembly comprising:a first fitting defining a first aperture; a secondfitting defining a second aperture; a first removable contaminationcontainment layer overlying the first aperture; a second removablecontamination containment layer overlying the second aperture; and anaxially resilient seat disposed between the first and second fittings,the first and second fittings being couplable to provide positivecontact between the first and second removable contamination containmentlayers, the axially resilient seat including a substantially cylindricalhub having a first diameter and a neck having a second diameter lessthan the first diameter, the hub defining a rim and the firstcontamination containment layer removably contacting the rim of the hub.4. A connector assembly comprising:a first fitting defining a firstaperture; a second fitting defining a second aperture; a first removablecontamination containment layer overlying the first aperture; a secondremovable contamination containment layer overlying the second aperture;and an axially resilient seat disposed between the first and secondfittings, the first and second fittings being couplable to providepositive contact between the first and second removable contaminationcontainment layers and the axially resilient seat including asubstantially cylindrical hub and a neck, wherein the hub defines a rimand the first contamination containment layer removably contacts the rimand wherein at least one of the hub and neck is axially compressible. 5.A connector assembly comprising:a first fitting defining a firstaperture and including a first removable contamination containment layeroverlying the first aperture; a second fitting defining a secondaperture and including a second removable contamination containmentlayer overlying the second aperture; a resilient coupling mechanismpositioned between the first and second fittings at the first and secondapertures; an interlock mechanism including at least one tongueextending between the first and second fittings and adapted to engage acorresponding surface to interlock the first and second fittings, thefirst and second fittings being couplable to provide positive contactbetween the first and second contamination containment layers; and astem member mounted in the first fitting and including a head axiallymovable through the first fitting into the aperture of the secondfitting.
 6. The connector assembly according to claim 5, wherein thefirst fitting includes a wall defining a bore and the stem member isaxially slidable within the bore, wherein the stem member includes aplunger sealingly engaging the wall, and wherein the connector assemblyfurther comprises a seal positioned between the wall and the stemmember.
 7. The connector assembly according to claim 5, wherein thefirst fitting includes a sleeve defining a bore, the stem member isaxially slidable within the bore and the connector assembly furthercomprises a rachet mechanism arranged between the sleeve of the firstfitting and the stem member to resist retraction of the stem member fromthe second fitting.
 8. The connector assembly according to claim 5,wherein the first fitting includes a first wall defining a first boreand a second wall defining a second smaller bore and the stem memberincludes a plunger mounted at an end of the stem member opposite that ofthe head, wherein the plunger sealingly engages the first wall and isaxially slidable within the first bore and the stem member and head areaxially slidable within the second bore, and wherein the connectorassembly further comprises a seal disposed between the stem member andthe first wall.
 9. The connector assembly according to claim 5, whereinthe first fitting includes a first sleeve defining a first bore and asecond sleeve defining a second smaller bore, the stem member beingaxially slidable within the second bore, and wherein the connectorassembly further comprises a seal disposed between the stem member andthe first sleeve and a rachet mechanism arranged between the stem memberand the second sleeve.
 10. The connector assembly according to claim 5,wherein the aperture of the second fitting includes a bore and the stemmember is insertable into the bore, the stem member and the bore havingmateable tapered forms, whereby the stem member can be frictionallyengaged in the bore of the second fitting.
 11. The connector assemblyaccording to claim 10, wherein the second fitting further includes alarger counterbore communicating with the bore in the second fitting,the counterbore opening at the second aperture onto a seat and thesecond removable contamination containment layer contacting the seat.12. The connector assembly according to claim 5, wherein the resilientcoupling mechanism includes a first section comprising a substantiallycylindrical hub having a first diameter and defining a rim, and a secondsection coupling the first section to the first fitting and providing anaxially resilient connection between the first section and the firstfitting, the second section including a neck and having a seconddiameter less than the first diameter.
 13. The connector assemblyaccording to claim 12, wherein the resilient coupling mechanism isattached to the first fitting and the first removable contaminationcontainment layer contacts the hub of the resilient coupling mechanism.14. The connector assembly according to claim 5, wherein theinterlocking mechanism comprises a plurality of tongues extending fromthe second fitting, each tongue including a catch and a taper formed ata proximate end of the tongue, and wherein the interlock mechanismfurther comprises a plurality of grooves and corresponding surfaces, thetongues registering within the grooves and the catches abutting thecorresponding surfaces.
 15. The connector assembly according to claim 5,wherein the wherein the interlocked first and second fittings force thefirst and second removable contamination containment layers intocontact, and wherein the connector assembly further comprises a stoppositioned between the first and second fittings.
 16. The connectorassembly according to claim 5, wherein the stem member and the firstfitting comprise a telescoping arrangement.
 17. The connector assemblyaccording to claim 14, wherein the stem member includes a lockingportion.
 18. The connector assembly according to claim 5, wherein thefirst and second contamination containment layers are removable and arearranged to be removed after the first fitting is coupled to the secondfitting.
 19. The connector assembly according to claim 18, wherein thefirst and second removable contamination containment layers eachcomprise a tab.
 20. A connector assembly comprising:a first fittingdefining a first aperture and including a first sealing layer overlyingthe first aperture; a second fitting defining a second aperture andincluding a second sealing layer overlying the second aperture; aresilient coupling mechanism positioned between the first and secondfittings at the first and second apertures; an interlock mechanismincluding at least one tongue extending between the first and secondfittings and adapted to engage a corresponding surface to interlock thefirst and second fittings, the first and second fittings being couplableto provide positive contact between the first and second sealing layers;and a piercing member mounted in the first fitting and axially movablethrough the first fitting, through the sealing layers into the apertureof the second fitting.
 21. The connector assembly according to claim 20,wherein the resilient coupling mechanism includes a first sectioncomprising a substantially cylindrical hub having a first diameter anddefining a rim, and a second section coupling the first section to thefirst fitting and providing an axially resilient connection between thefirst section and the first fitting, the second section including a neckand having a second diameter less than the first diameter.
 22. Theconnector assembly according to claim 21, wherein the resilient couplingmechanism is attached to the first fitting and the first sealing layercontacts the hub of the resilient coupling mechanism.
 23. The connectorassembly according to claim 20, wherein the interlocking mechanismcomprises a plurality of tongues extending from the second fitting, eachtongue including a catch and a taper formed at a proximate end of thetongue, and wherein the interlock mechanism further comprises aplurality of grooves and corresponding surfaces, the tongues registeringwithin the grooves and the catches abutting the corresponding surfaces.24. The connector assembly according to claim 20, wherein the whereinthe interlocked first and second fittings force the first and secondsealing layers into contact, and wherein the connector assembly furthercomprises a stop positioned between the first and second fittings. 25.The connector assembly according to claim 20, wherein the piercingmember and the first fitting comprise a telescoping arrangement.
 26. Theconnector assembly according to claim 25, wherein the piercing memberincludes a locking portion.
 27. A connector assembly comprising:a firstfitting defining a first aperture, and including a first removablecontamination containment layer overlying the first aperture; a secondfitting coupled to the first fitting, defining a second aperture, andincluding a second removable contamination containment layer overlyingthe second aperture; a stem member mounted in the first fitting andincluding a head axially movable into the aperture of the secondfitting; and a breakable or severable element positioned between thefirst fitting and the stem member and providing resistance to axialmovement of the stem member into the second fitting.
 28. The connectorassembly according to claim 27, wherein the element is sealinglyconnected between the first fitting and the stem member.
 29. Theconnector assembly according to claim 28, wherein the element comprisesa frangible element.
 30. The connector assembly according to claim 29,wherein the frangible element comprises a thin wall extending betweenthe stem member and the first fitting.
 31. The connector assemblyaccording to claim 30, wherein the first fitting includes a seatassembly and the frangible element is fixed to the seat assembly. 32.The connector assembly according to, claim 31 wherein the seat assemblyincludes a rim arranged to sever the frangible element as the stemmember moves toward the second fitting.
 33. The connector assemblyaccording to claim 32, wherein the frangible element includes a cleavageor crease which cooperates with the rim to sever the frangible element.34. The connector assembly according to claim 33, wherein the rimincludes a sharp edge which coincides with the cleavage or crease in thefrangible element.
 35. The connector assembly according to claim 32,wherein the rim includes a sharp edge.
 36. The connector assemblyaccording to claim 32, wherein a portion of the severed flange isattached to the stem member, wherein the first fitting includes a walldefining a bore, the stem member being disposed within the bore, andwherein the severed portion of the flange contacts the wall of the boreas the stem member moves toward the second fitting.
 37. The connectorassembly according to claim 27, wherein the breakable or severableelement seals the stem member.
 38. A connector assembly comprising:afirst fitting defining a first aperture and including a first removablecontamination containment layer overlying the first aperture; a secondfitting defining a second aperture and including a second removablecontamination containment layer overlying the second aperture; aninterlock mechanism including at least one tongue extending between thefirst and second fittings and adapted to engage a corresponding surfaceto interlock the first and second fittings, the first and secondfittings being coupled to provide positive contact between the first andsecond removable contamination containment layers; a stem member mountedin the first fitting and including a head axially movable into theaperture of the second fitting; and an axial restraint coupled to thestem member to resist retraction of the stem member from the secondfitting.
 39. The connector assembly according to claim 38, wherein theaxial restraint comprises a rachet mechanism including a plurality ofribs mounted between the stem member and the first fitting.
 40. Aconnector assembly comprising:a first fitting defining a first apertureand including a first sealing layer overlying the first aperture; asecond fitting defining a second aperture and including a second sealinglayer overlying the second aperture; an interlock mechanism including atleast one tongue extending between the first and second fittings andadapted to engage a corresponding surface to interlock the first andsecond fittings, the first and second fittings being coupled to providepositive contact between the first and second sealing layers; a piercingmember mounted in the first fitting and axially movable through thesealing layers into the aperture of the second fitting; and an axialrestraint coupled to the piercing member to resist retraction of thepiercing member from the second fitting.
 41. The connector assemblyaccording to claim 40, wherein the axial restraint comprises a rachetmechanism including a plurality of ribs mounted between the piercingmember and the first fitting.
 42. A connector assembly comprising:afirst fitting defining a first aperture and including a first removablecontamination containment layer overlying the first aperture; a secondfitting coupled to the first fitting, defining a second aperture andincluding a second removable contamination containment layer overlyingthe second aperture; a stem member mounted in the first fitting andincluding a head axially movable into the aperture of the secondfitting; and a ratchet mechanism mounted to the stem member to lock thestem member within the second aperture of the second fitting.
 43. Theconnector assembly according to claim 42, wherein the first fittingincludes a sleeve and the stem member includes a stem axially slidablewithin the sleeve, wherein the stem includes a plurality of ribscircumscribing and extending at an acute angle from the stem, andwherein the sleeve includes a catch engageable with at least one of theribs to prevent retraction of the stem member.
 44. The connectorassembly according to claim 42, wherein the ratchet mechanism includes aplurality of ribs and a structure which is engageable with at least oneof the ribs, the ribs being fixed to one of the first fitting and thestem member and the engageable structure being fixed to the other of thefirst fitting and the stem member.
 45. The connector assembly accordingto claim 44, wherein at least one of the ribs and the engageablestructure are arranged to provide sufficient resistance to preventaccidental or incidental movement of the stem member.
 46. The connectorassembly according to claim 44, wherein the stem member includes a stemand the ribs are fixed to the stem.
 47. The connector assembly accordingto claim 46, wherein the ribs circumscribe the stem and extend at anacute angle from the stem.
 48. The connector assembly according to claim46, wherein the first fitting includes a sleeve and the engageablestructure includes a catch mounted to the sleeve, the stem beingslidably disposed within the sleeve.
 49. The connector assemblyaccording to claim 48, wherein the catch comprises a first catch andwherein the first fitting includes a second catch spaced from the firstcatch and engageable with at least one of the ribs.
 50. The connectorassembly according to claim 49, wherein the second catch is spacedaxially from the first catch.
 51. The connector assembly according toclaim 42, further comprising a resilient coupling mechanism positionedbetween the first and second fittings at the first and second apertures,the resilient coupling mechanism comprising a hub and a smaller diameterneck coupled to the hub.
 52. The connector assembly according to claim45, wherein the first removable contamination containment layer contactsthe hub.
 53. The connector assembly according to claim 43, furthercomprising a resilient coupling mechanism positioned between the firstand second fittings, the coupled first and second fittings compressingthe resilient coupling mechanism and forcing the first and secondcontamination containment layers into contact, and a stop positionedbetween the first and second fittings to limit compression of theresilient coupling mechanism.
 54. The connector assembly according toclaim 42, further comprising an interlock mechanism coupling the firstand second fittings in a predetermined relation.
 55. The connectorassembly according to claim 54, wherein the interlock mechanism includesa plurality of tongues extending between the first and second fittingsand adapted to engage corresponding surfaces to interlock the first andsecond fittings.
 56. The connector assembly according to claim 42,further comprising a resilient coupling mechanism positioned between thefirst and second fittings at the first and second apertures and aninterlock mechanism locking the first fitting to the second fitting. 57.The connector assembly according to claim 56, wherein the resilientcoupling mechanism comprises a hub and a smaller diameter neckresiliently mounted to the hub and connected to the first fitting andwherein the interlock mechanism comprises a plurality of tonguesextending between the first and second fittings, each tongue beingreceived in a groove and engaging a surface.
 58. The connector assemblyaccording to claim 42, wherein the first fitting includes a walldefining a bore and the stem member is axially slidable within the bore,wherein the stem member includes a plunger sealingly engaging the walland wherein the connector assembly further comprises a seal positionedbetween the wall and the stem member.
 59. The connector assemblyaccording to claim 42, wherein the first fitting includes a sleevedefining a bore, the stem member includes a stem and a head mounted tothe stem, and the head and the stem are axially slidable within the boreand wherein the ratchet mechanism is arranged between the sleeve of thefirst fitting and the stem of the stem member to resist retraction ofthe stem member from the second fitting.
 60. The connector assemblyaccording to claim 42, wherein the first fitting includes a first walldefining a first bore and a second wall defining a second smaller boreand the stem member includes a stem, a head mounted to one end of thestem, and a plunger mounted at the other end of the stem, wherein theplunger sealingly engages the first wall and is axially slidable withinthe first bore and the head and the stem are axially slidable within thesecond bore, and wherein the connector assembly further comprises a sealdisposed between the stem member and the first wall.
 61. The connectorassembly according to claim 42, wherein the first fitting includes afirst sleeve defining a first bore and a second sleeve defining a secondsmaller bore and the stem member includes a stem and a head mounted toone end of the stem, the head and the stem being axially slidable withinthe second bore and the ratchet mechanism being arranged between thestem and the second sleeve, and wherein the connector assembly furthercomprises a seal disposed between the piercing member and the firstsleeve.
 62. The connector assembly according to claim 42, wherein thefirst fitting includes a resilient mount positioned at the firstaperture and wherein the first fitting, including the resilient mount,is integrally molded as a single part from a polymeric material.
 63. Theconnector assembly according to claim 62, wherein the resilient mountincludes a neck and a larger diameter hub mounted to the neck.
 64. Theconnector assembly according to claim 62, further comprising at leastone tongue extending between the first and second fittings to interlockthe fittings, wherein the tongue and one of the first and secondfittings are integrally molded as a single part from a polymericmaterial.
 65. The connector assembly according to claim 42, wherein thesecond fitting includes a bore communicating with the second apertureand the stem member includes a head insertable into the bore, the headand the bore having mated tapered forms whereby the head can befrictionally engaged in the bore of the second fitting.
 66. Theconnector assembly according to claim 65, wherein the second fittingfurther includes a larger counterbore communicating with the bore in thesecond fitting, the counterbore opening at the second aperture onto aseat and the second removable contamination containment layer contactingthe seat.